Intervertebral cage apparatus and system and methods of using the same

ABSTRACT

An intervertebral cage and intervertebral cage apparatus and a method for using the intervertebral cage and/or the intervertebral cage apparatus. The intervertebral cage can be any desired material including a memory material. The intervertebral cage apparatus can include the intervertebral cage and one or both of a variable volume pouch and a deployment cable. The variable volume pouch can be inserted into an internal volume of the intervertebral cage and affixed to the intervertebral cage. The variable volume pouch can be filled with material to achieve an expanded state. The variable volume pouch can assist in the deployment of the intervertebral cage. The deployment cable can be attached to the intervertebral cage and can include features to facilitate that attachment. The deployment cable can apply a force to the intervertebral cage to deploy the intervertebral cage, and can include features to lock the intervertebral cage in the deployed configuration. An implantation tool can be used to apply force to the intervertebral cage to deploy the intervertebral cage.

RELATED APPLICATIONS

The present application is a national stage application under 35 U.S.C.§ 371 of PCT Application No. PCT/US2013/056500, filed Aug. 23, 2013,which claims priority to U.S. Provisional Application No. 61/693,738filed Aug. 27, 2012, entitled INTERVERTEBRAL CAGE APPARATUS AND SYSTEMAND METHODS OF USING THE SAME and U.S. Provisional Application No.61/778,271 filed Mar. 12, 2013, entitled INTERVERTEBRAL CAGE APPARATUSAND SYSTEM AND METHODS OF USING THE SAME, the entire contents of both ofwhich are hereby expressly incorporated by reference.

BACKGROUND OF THE INVENTION

Field of the Invention

This application relates to the field of intervertebral implants.

Description of the Related Art

Current intervertebral devices are designed using three majorprinciples: the anatomical limitations of the surgical approach,optimization of bone graft volume to promote bone fusion, andoptimization of the device contact with vertebral end plates to resistsubsidence. Current devices are generally static in that they cannotchange shape or volume. Thus, current devices are limited by anatomy andtechnique and consequently may not provide optimal bone graft volume orsurface contact.

Other current intervertebral devices can change their shape and volume;however, these devices lack rigid components. As a result of this, whilethese devices are able to change their shape and/or volume, thesedevices do not provide for stable contact with vertebral end plates.

SUMMARY OF THE INVENTION

Certain embodiments of the present application relate to intervertebralimplants and methods of using the same. For example, certain embodimentsrelate to an intervertebral cage, a deployment cable, a variable volumepouch, and/or an applicator device.

Some embodiments relate to an intervertebral cage that can be configuredfor positioning between two vertebrae and specifically between twovertebral end plates. In some embodiments, the intervertebral cage canbe configured for expansion parallel to the vertebral end plates and/orfor expansion perpendicular to the vertebral end plates. In someembodiments, the vertebral cage can be configured for use with avariable volume pouch and/or with a deployment cable. In someembodiments, for example, the variable volume pouch can be positionedwithin an internal volume of the intervertebral cage, and can be affixedto portions of the intervertebral cage. In some embodiments, forexample, the expansion of the variable volume pouch can be facilitatedby the deployment of the intervertebral cage, and in some embodiments,for example, the deployment of the intervertebral cage can befacilitated by the expansion of the variable volume pouch.

In some embodiments, the intervertebral cage can be deployed with adeployment cable. In some embodiments, the deployment cable can beconfigured to pass through all or portions of the intervertebral cageand to transmit force to the intervertebral cage to deploy theintervertebral cage. In some embodiments, the deployment cable caninclude an attachment feature configured to allow the deployment cableto be attached to the intervertebral cage, and in some embodiments, thedeployment cable can include a locking feature configured to allow forlocking the intervertebral cage into a deployed position with thedeployment cable.

In some embodiments, for example, the intervertebral cage can be usedwith a variable volume pouch and with the deployment cable. In suchembodiments, for example, the variable volume pouch can be positionedwithin a variable volume portion of the intervertebral cage and can beaffixed to the intervertebral cage, at least in part, via the deploymentcable. In one specific embodiment, the deployment cable can pass througha portion of the intervertebral cage and into and through a portion ofthe variable volume pouch, before passing again through a portion of theintervertebral cage. Advantageously, such use of the deployment cableand the variable volume pouch can simplify the affixation of thevariable volume pouch to the intervertebral cage.

Some embodiments relate to methods of using a variable volume pouch inconnection with an intervertebral cage to form an intervertebral cageapparatus. In some embodiments, such a method can include, for example,inserting a variable volume pouch into an intervertebral implant,affixing the variable volume pouch to all or portions of theintervertebral implant, and filling the variable volume pouch.

Some embodiments relate to methods of using the deployment cable inconnection with the intervertebral cage. In some embodiments, forexample, these methods can include inserting a deployment cable throughall or portions of an intervertebral cage and applying a force to theintervertebral cage via the deployment cable.

Some embodiments relate to an intervertebral cage apparatus that caninclude, an intervertebral cage that can be moved from a firstundeployed position to a second deployed position, and a deployment toolincluding a deployment cable having a first end and a second end, and acontroller. In some embodiments, the first end of the deployment cableis connectable to a portion of the intervertebral cage and in someembodiments the second end of the deployment cable is connected to thecontroller. In some embodiments, the manipulation of the controllertransmits force to the cable to move the intervertebral cage from thefirst position to the second position.

In some embodiments of the intervertebral cage apparatus, theintervertebral cage includes a body having a plurality of segmentsconnected to each other by flexible connectors, and the movement of thecage from the first position to the second position decreases thedistance between a proximal end and a distal end of the cage andincreases a width of the body. In some embodiments of the intervertebralcage apparatus, the flexible connectors comprise living hinges. In someembodiments of the intervertebral cage apparatus, the intervertebralcage includes a lateral split. In some embodiments of the intervertebralcage apparatus, the intervertebral cage is configured to change itsdimension along each of a longitudinal axis, a lateral axis, and avertical axis when the intervertebral cage is moved from a firstundeployed position to a second deployed position.

In some embodiments of the intervertebral cage apparatus, theintervertebral cage includes a first opening at a proximal end of thecage that can attach to the first end of the deployment cable, one ormore openings at a distal end of the cage, and a second opening at aproximal end of the cage. In some embodiments, the cable can extend fromthe first opening to an opening at the distal end of the cage, and canextend from an opening at the distal end of the cage through the secondopening and to the controller. In some embodiments of the intervertebralcage apparatus, the intervertebral cage includes a circuitous bodypartially defining an internal volume.

In some embodiments the intervertebral cage apparatus further includes avariable volume pouch having a first end with an opening and a sealedend located opposite the first end. In some embodiments, the variablevolume pouch is positionable in an internal volume of the intervertebralcage such that the first end is proximate to a proximal aperture of theintervertebral cage. In some embodiments of the intervertebral cageapparatus, the variable volume pouch is affixed to the intervertebralcage, and in some embodiments, the variable volume pouch is affixed tothe intervertebral cage using the deployment cable.

In some embodiments of the intervertebral cage apparatus, theintervertebral cage comprises a memory material, and in someembodiments, the memory material comprises a memory PEEK material.

Some embodiments relate to an intervertebral cage apparatus including anintervertebral cage comprising a memory material and that can move froma first undeployed position to a second deployed position, theintervertebral cage including a body having a plurality of segmentsconnected to each other by flexible connectors. In some embodiments, themovement of the cage from the first position to the second positiondecreases the distance between a proximal end and a distal end of thecage and increases a width of the body.

In some embodiments of the intervertebral cage apparatus, the memorymaterial comprises a memory PEEK material.

Some embodiments relate to a method of using an intervertebral cageapparatus. The method of using an intervertebral cage apparatus caninclude, for example, positioning an expandable intervertebral cage madeof a memory material into an intervertebral disc space, theintervertebral cage including a circuitous body defining an internalvolume and having a plurality of segments connected to each other byflexible connectors, and applying a trigger to the intervertebral cage.In some embodiments, the application of the trigger causes the memorymaterial to transition shape via bending about the flexible connectorsfrom an undeployed configuration to a deployed configuration.

Some embodiments relate to a method of using an intervertebral cageapparatus including positioning an expandable intervertebral cage intoan intervertebral disc space, the intervertebral cage including acircuitous body defining an internal volume and having a plurality ofsegments connected to each other by flexible connectors, and applying aforce to a deployment cable attached to the intervertebral cage. In someembodiments, the application of force causes bending about the flexibleconnectors to move the cage from an undeployed position to a deployedposition.

In some embodiments, the method of using an intervertebral cageapparatus includes locking the position of the cage in the deployedposition. In some embodiments, the method of using an intervertebralcage apparatus includes disengaging a portion of the deployment cablefrom the cage after the cage is in its deployed position. In someembodiments, the method of using an intervertebral cage apparatusincludes delivering bone graft material through a proximal opening inthe cage.

In some embodiments, the method of using an intervertebral cageapparatus includes positioning a variable volume pouch within theinternal volume of the cage. In some embodiments of a method of using anintervertebral cage apparatus, the variable volume pouch is positionedwithin the internal volume of the cage prior to positioning the cageinto the intervertebral disc space. In some embodiments of the method ofusing an intervertebral cage apparatus, the variable volume pouch ispositioned within the internal volume of the cage after positioning thecage into the intervertebral disc space. In some embodiments of themethod of using an intervertebral cage apparatus, the variable volumepouch is affixed to the cage. In some embodiments of the method of usingan intervertebral cage apparatus, the variable volume pouch is affixedto the cage with the deployment cable, and the deployment cable passesthrough openings in the variable volume pouch. In some embodiments, themethod of using an intervertebral cage apparatus includes filling thevariable volume pouch through an opening in the variable volume pouch,said opening being located in a proximal aperture of the cage. In someembodiments, the method of using an intervertebral cage apparatusincludes inserting a plug into the proximal aperture of theintervertebral cage.

Some embodiments relate to a system for deploying an intervertebral cagebetween two vertebrae which include an intervertebral cage apparatusconfigured to be moved from a first undeployed position to a seconddeployed position and an implantation tool with an outer cannula havinga connector and a shaft having one or more pins. In some embodiments, adistal end of the intervertebral cage apparatus has a distal aperture.In some embodiments, the distal aperture additionally includes slots forthe one or more pins. In some embodiments, the connector of theimplantation tool has mating portions which may comprise teeth and aproximal portion of the intervertebral cage apparatus has cutoutsconfigured to receive the mating portions.

In some embodiments, the method of using an intervertebral cageapparatus includes positioning an intervertebral cage apparatus into anintervertebral disc space, applying a relative force between a proximalend and a distal end of the intervertebral cage apparatus, and whereinan outer member of an implantation tool engages the proximal end and aninner member of the implantation tool engages the distal end. In someembodiments, applying the relative force is performed by applying aforce in a distal direction to the proximal end while preventingtranslation of the distal end. In some embodiments, applying therelative force is performed by applying a force in a proximal directionto the distal end while preventing translation of the proximal end. Insome embodiments, the distal end of the intervertebral cage apparatusincludes slots and the method includes engaging pins to the distal end.

Some embodiments relate to a tool for implanting an intervertebral cageapparatus having a handle, a control member, an outer member attached tothe handle, the outer member having a connector configured to engage aproximal end of an intervertebral cage apparatus, and an inner memberattached to the control member, the inner member having pins configuredto engage a distal end of the intervertebral cage apparatus. In someembodiments, the connector has a mating portion which protrudes distallyfrom the connector and which is configured to engage a cutout on aproximal end of the intervertebral cage apparatus.

The foregoing is a summary and thus contains, by necessity,implications, generalizations, and omissions of detail; consequently,those skilled in the art will appreciate that the summary isillustrative only and is not intended to be in any way limiting. Otheraspects, features, and advantages of the devices and/or processes and/orother subject matter described herein will become apparent in theteaching set forth herein. The summary is provided to introduce aselection of concepts in a simplified form that are further describedbelow in the detailed description. This summary is not intended toidentify key features or essential features of the claimed subjectmatter, nor is it intended to be used as an aide in determining thescope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present disclosure will becomemore fully apparent from the following description and appended claims,taken in conjunction with the accompanying drawings. Understanding thatthese drawings depict only several embodiments in accordance with thedisclosure and are not to be considered limiting of its scope, thedisclosure will be described with additional specificity and detailthrough the use of the accompanying drawings.

FIG. 1A is a perspective view of one embodiment of an intervertebralcage in an undeployed position.

FIG. 1B is a top view of one embodiment of an intervertebral cage in anundeployed configuration.

FIG. 2A is a perspective view of one embodiment of an intervertebralcage in a deployed configuration.

FIG. 2B is a top view of one embodiment of an intervertebral cage in adeployed configuration.

FIG. 3 is a perspective view of one embodiment of an intervertebral cageincluding a lateral split in an undeployed position.

FIG. 4A is a perspective view of one embodiment of a variable volumepouch in an unexpanded configuration.

FIG. 4B is a perspective view of one embodiment of a variable volumepouch in an expanded configuration.

FIG. 5A is a perspective view of one embodiment of an intervertebralcage apparatus including an intervertebral cage and a variable volumepouch in an undeployed configuration.

FIG. 5B is a side view of one embodiment of a plug.

FIG. 6A is a perspective view of one embodiment of an intervertebralcage apparatus including an intervertebral cage and a variable volumepouch in a deployed configuration.

FIG. 6B is a top cutaway view of one embodiment of an intervertebralcage apparatus in a deployed configuration.

FIG. 7 is a perspective view of one embodiment of an intervertebral cageapparatus including a variable volume pouch and an intervertebral cagehaving a lateral split in a deployed configuration.

FIG. 8 is a schematic illustration of one embodiment of a deploymentsystem.

FIG. 9 is a perspective view of one embodiment of an intervertebral cageapparatus including an intervertebral cage and a deployment cable in anundeployed configuration.

FIG. 10A is a perspective view of one embodiment of an intervertebralcage apparatus including an intervertebral cage and a deployment cablein a deployed configuration.

FIG. 10B is a top view of one embodiment of an intervertebral cageapparatus including an intervertebral cage and a deployment cable in adeployed configuration.

FIG. 11 is a perspective view of one embodiment of an intervertebralcage apparatus including a variable volume pouch, a deployment cable,and an intervertebral cage having a lateral split in a deployedconfiguration.

FIG. 12 is a flowchart illustrating one embodiment of process for usingthe intervertebral cage and/or the intervertebral cage apparatus.

FIG. 13 is a flowchart illustrating one embodiment of a method of usinga variable volume pouch and an intervertebral cage as part of anintervertebral cage apparatus.

FIG. 14 is a flowchart illustrating one embodiment of a method of usingan intervertebral cage apparatus including an intervertebral cage and adeployment cable.

FIG. 15A is a perspective view of one embodiment of an intervertebralcage apparatus having a distal aperture in an undeployed position.

FIG. 15B is a cross-sectional view of one embodiment of anintervertebral cage apparatus along section A-A as shown in FIG. 15A.

FIG. 15C is a cross-sectional view of one embodiment of anintervertebral cage apparatus along section B-B as shown in FIG. 15Bshowing a slot on a distal aperture.

FIG. 16A is a partial cross-sectional view of one embodiment of animplantation tool which can be used to convert an intervertebral cageapparatus from an undeployed position to a deployed position.

FIG. 16B is an enlarged view of a distal end of one embodiment of animplantation tool focused on Section A-A as shown in FIG. 16A.

FIG. 16C is a view from the distal end of one embodiment of animplantation tool showing the distal end of an intervertebral cageapparatus having a connector, teeth, and shaft.

FIG. 17 is a cross-sectional view of one embodiment of theintervertebral cage apparatus having a distal aperture and oneembodiment of an implantation tool prior to being connected.

DETAILED DESCRIPTION

The Intervertebral Cage

As shown in FIGS. 1A and 1B and in FIGS. 2A and 2B, an intervertebralimplant, preferably an intervertebral cage 100 is provided. Althoughsome details of the intervertebral cage 100 and methods of use areprovided herein, further details can be found in U.S. Publication No.2012/0083887 published on Apr. 5, 2012, entitled “Intervertebral Deviceand Methods of Use,” and in U.S. Publication No. 2012/0083889 publishedon Apr. 5, 2012, entitled “Intervertebral Device and Methods of Use,”both of which are incorporated herein in their entirety by reference.Both of these publications are further found attached in Appendix A,which material constitutes part of the present application.

The intervertebral cage 100 can be configured for positioning betweentwo vertebrae and specifically for positioning between the end plates oftwo vertebrae. The intervertebral cage 100 can be positioned in anundeployed configuration as depicted in FIGS. 1A and 1B and can bepositioned in a deployed configuration as depicted in FIGS. 2A and 2B.In some embodiments, and as depicted in FIGS. 1A-B and 2A-B, the changeof the intervertebral cage 100 from an undeployed configuration to adeployed configuration can result in a change of the dimensions andshape of the intervertebral cage 100.

The intervertebral cage 100 can comprise a body 102. The body 102 can beconfigured to contact the two vertebrae between which the intervertebralcage 100 is positioned and/or to transfer force from one of thevertebrae between which the intervertebral cage 100 is positioned to theother of the vertebrae between which the intervertebral cage ispositioned. The body 102 can comprise a variety of shapes and sizes andcan be made from a variety of materials.

In some embodiments, for example, the body 102 can comprise a circuitousbody defining a perimeter and an internal volume. In some embodiments,the body 102 can be sized and shaped for positioning between twovertebrae, and thus, can comprise dimensions and shapes that approximatethe dimensions and shape of the space between the two vertebrae.

In some embodiments, the body 102 can comprise a biocompatible materialincluding, for example, a natural biocompatible material, a syntheticbiocompatible material, a metallic biocompatible material, and/or anyother desired biocompatible material. In some specific embodiments, thebody 102 can be made of polyetherketone (PEK), polyetherimide (PEI),such as Ultem, ultrahigh molecular weight polyethylene (UHMPE),polyphenylene, polyether-ether-ketone (PEEK), or any other desiredbiocompatible material. In some embodiments, the body 102 can comprise amemory material. In some specific embodiments, the body 102 can comprisea memory PEEK material such as, for example, PEEK Altera™. In one suchembodiment in which a memory material is used for the body 102, the body102 can be configured such that the deployed configuration is the firstposition to which the body 102 returns when the memory material istriggered and that the undeployed configuration is the second position.In such an embodiment, the body 102 of the intervertebral cage 100 canbe positioned within an intervertebral space when the body 102 is in theundeployed, second position. After the body 102 has been properlypositioned within the intervertebral space, the memory material can betriggered and the body can return to the deployed, first position.

The body 102 can have a proximal end 110 and a distal end 112. In someembodiments, the proximal end 110 and/or the distal end 112 can be anintegral part of the body 102 and can partially define the internalvolume of the body 102. In some embodiments, the proximal end 110 of thebody 102 can be configured for interaction with an insertion tool toallow insertion of the intervertebral cage 100 and for the deployment ofthe intervertebral cage 100. In some embodiments, and as seen in FIG.2A, the proximal end 110 of the body 102 can comprise a proximalaperture 124. In some embodiments, for example, the proximal aperture124 can extend through the proximal end 110 of the body 102 and into theinternal volume 126 of the body 102. Advantageously, in embodiments inwhich the proximal aperture 124 extends through the proximal end 110 ofthe body 102 and into the internal volume 126 of the body 102, theproximal aperture 124 can provide access to the internal volume 126and/or components or features of an intervertebral cage apparatuslocated within the internal volume 126. The proximal end 110 cancomprise a variety of shapes and sizes. Similarly, the proximal aperture124 can comprise a variety of shapes and sizes.

The distal end 112 of the body 102 can be configured to facilitateinsertion of the intervertebral cage 100 between the vertebrae. In someembodiments, for example, the distal end 112 of the body 102 cancomprise a tapered and/or pointed shape to facilitate insertion of thebody 102 into the space between the vertebrae. Advantageously, such atapered and/or pointed shape to the distal end of the body 102 canfacilitate in achieving adequate separation between the vertebrae and/orcan minimize the insertion force required to insert the body 102 of theintervertebral cage 100 into the space between the vertebrae.

As seen in FIG. 1A, a longitudinal axis 104 of the body 102 can extendbetween the proximal end 110 and the distal end 112 of the body. Asfurther seen in FIG. 1A, the body 102 can comprise a top 120 and abottom 122. In some embodiments, the top 120 and the bottom 122 can eachbe configured for interaction with one of the vertebrae between whichthe intervertebral cage 100 is positioned, and specifically forinteraction with one of the end plates of one of the vertebrae betweenwhich the intervertebral cage 100 is positioned. As also seen in FIG.1A, the body 102 can define a vertical axis 108 extending perpendicularto the longitudinal axis 104 and between the top 120 and the bottom 122of the body 102. As further seen in FIG. 1A, the body 102 can define alateral axis 106 extending perpendicular to both the longitudinal axis104 and the vertical axis 108.

As seen in FIGS. 1A-B and in FIGS. 2A-B, some embodiments of the body102 can comprise segments 116 connected to each other by flexibleconnectors 118, which can comprise any bendable connector, including,for example, one or several living hinges. In some embodiments, forexample, the segments 116 can comprise elongate members which arebounded by the flexible connectors 118. The flexible connectors 118 can,in some embodiments, be located on an interior surface of the body 102proximate to the internal volume 126, and in some embodiments, theflexible connectors 118 can be located on an exterior surface of thebody 102. In some embodiments, the flexible connectors 118 can compriseportions of the body 102 that are configured to bend. In someembodiments, the flexible connectors 102 can be discrete elements inthat the bending may be localized in one or several positions on thebody 102, and in some embodiments, the flexible connectors 102 may benon-discrete elements in that the bending may not be localized, butrather occur over all or large portions of the body 102. In someembodiments in which the flexible connectors 118 comprise discreteelements, the flexible connector can comprise a shape, a feature, amaterial characteristic, or any other aspect that concentrates stressesand/or deformation. As specifically depicted in FIGS. 1A-B and 2A-B, insome embodiments, the flexible connectors 118 can comprise narrowedportions of the body 102 and/or cutouts into the body 102 to allowlocalized deformations of the body 102 when the body 102 is moved froman undeployed configuration to a deployed configuration.

The segments 116 and the flexible connectors 118 can comprise a varietyof shapes and sizes. In some embodiments, for example, the shapes andsizes of the segments 116 and/or the flexible connectors 118 can bedetermined by the desired size of the intervertebral cage 100, thedesired deployment force, the desired deployed resulting shape, thedesired undeployed shape, and/or a number of other considerations.

As seen in FIGS. 1A-B and 2A-B, the combination of the segments 116 andthe flexible connectors 118 allow deployment of the body 102 of theintervertebral cage 100, which deployment decreases the distance betweenthe proximal end 110 and the distal end 112 and increases the width ofthe body 102 as measured along the lateral axis 106.

In some embodiments, an intervertebral cage 100 can be configured suchthat dimensions of the intervertebral cage 100 vary along one, two, orthree of the above discussed axes 104, 106, 108 when the intervertebralcage 100 is moved from an undeployed configuration to a deployedconfiguration. FIG. 3 depicts such an embodiment of an intervertebralcage 300 configured for dimensional change along three of its axes 104,106, 108. The intervertebral cage 300 depicted in FIG. 3 comprises abody 102 having a proximal end 110 and a distal end 112. The body 102defines a longitudinal axis 104 extending down the center of the body102 and between the proximal end 110 and the distal end 112. The body102 of the intervertebral cage 300 depicted in FIG. 3 further comprisesa top 120 and a bottom 122 and defines a vertical axis 108 extendingbetween the top 120 and the bottom 122 and perpendicular to thelongitudinal axis 104. The body 102 of the intervertebral cage 300further defines a lateral axis 106 which extends perpendicular to boththe longitudinal axis 104 and the vertical axis 108.

The body 102 of the intervertebral cage 300 depicted in FIG. 3 furthercomprises a plurality of segments 116 joined by flexible connectors 118.The segments 116 and flexible connectors 118 of the body 102 define aninternal volume 126 of the body 102.

As also seen in FIG. 3, the body 102 of the intervertebral cage 300comprises a lateral split 302. The lateral split 302 can be configuredto allow the expansion of the body 102 of the intervertebral cage 300.In some embodiments, for example, the lateral split 302 can beconfigured to allow the expansion of all or a portion of the body 102 ofthe intervertebral cage 300 in a direction perpendicular to the lateralsplit 302.

The lateral split 302 can comprise a variety of sizes and shapes. Insome embodiments, for example, the lateral split 302 can extend from oneend of the body 102 towards another end of the body 102. As specificallydepicted in FIG. 3, the lateral split 302 extends from the distal end112 of the body 102 towards the proximal end 110 of the body 102. Thelength of the lateral split 302 can vary based on the desired amount ofexpansion allowed by the lateral split 302. In some embodiments, forexample, the lateral split 302 can extend for 5% of the length of thebody, 10% of the length of the body, 25% of the length of the body, 50%of the length of the body, 75% of the length of the body, 90% of thelength of the body, or any other intermediate or other desired percentof the length of the body as measured along one of the axes 104, 106,108 of the body 102.

As further seen in FIG. 3, the lateral split 302 comprises a first end304 and a second end 306. As specifically depicted in FIG. 3, the firstend 304 of the lateral split 302 is located proximate to the distal end112 of the body 102 and the second end 306 of the lateral split 302 islocated approximately in the middle of the body 102. As also seen inFIG. 3, the lateral split 302 divides the body 102 at least partiallyinto a top portion 308 and a bottom portion 310. As seen in FIG. 3, thetop portion 308 is located between the top 120 of the body 102 of theintervertebral cage 300 and the lateral split 302 and the bottom portion310 is located between the bottom 122 of the body 102 of theintervertebral cage 300 and the lateral split 302. Advantageously, thedivision of the body 102 into a top portion 308 and into a bottomportion 310 by a lateral split 302 allows the expansion of the body 102of the intervertebral cage 300. In some embodiments, for example, thisexpansion of the body 102 of the intervertebral cage 300 can beperpendicular to the lateral split 302, and in some embodiments, thisexpansion of the body 102 can be nonperpendicular to the lateral split302. As specifically depicted in FIG. 3, the top portion 308 and thebottom portion 310 of the body 102 allow the expansion of the body 102in a direction parallel to the lateral axis 106 by the expansion of thelateral split 302.

The Variable Volume Pouch

Some embodiments of an intervertebral cage apparatus can include avariable volume pouch. FIG. 4A depicts a perspective view of oneembodiment of a variable volume pouch 400 in an unexpanded state andFIG. 4B depicts one embodiment of a variable volume pouch 400 in anexpanded state. The variable volume pouch 400 can be configured forexpansion in response to receiving material in an internal portion ofthe variable volume pouch 400. In some embodiments, the variable volumepouch 400 can be configured to resist compressive forces when thevariable volume pouch 400 is filled with material. One example of avariable volume pouch is the OptiMesh® Deployable Grafting Systemavailable from Spineology, Inc. Although some details of the variablevolume pouch 400 and methods of use are provided herein, further detailscan be found in U.S. Pat. No. 5,549,679 published on Mar. 1, 1995,entitled “Expandable Fabric Implant For Stabilizing the Spinal MotionSegment,” and in U.S. Pat. No. 5,571,189 published on Nov. 5, 1996,entitled “Expandable Fabric Implant For Stabilizing the Spinal MotionSegment,” both of which are incorporated herein in their entirety byreference. Both of these patents are further found attached in AppendixA, which material constitutes part of the present application.

The variable volume pouch can comprise a variety of shapes and sizes. Insome embodiments, for example, the variable volume pouch 400 can beshaped to allow uniform expansion of the variable volume pouch 400 whenmaterial is added into the internal portion of the variable volume pouch400. In some embodiments, for example, the variable volume pouch can beapproximately spherical, ovular, elongate, cylindrical, rectangular, orhave any other desired shape. In the embodiment depicted in FIGS. 4A and4B, the variable volume pouch 400 is approximately balloon shaped. Asalso seen in FIGS. 4A and 4B, the variable volume pouch 400 comprises afirst end 402 and a second end 404 positioned opposite the first end402. As seen in FIGS. 4A and 4B, the variable volume pouch 400 furthercomprises a single opening 406 located at the first end 402.

In some embodiments, the variable volume pouch 400 can include featuresconfigured to allow the selectable sealing and/or closing of the opening406. These features can include, for example, one or several ties, oneor several drawstrings, one or several plugs, or any other mechanical orother feature configured to allow the sealing and/or closing of theopening 406.

The variable volume pouch 400 can comprise a variety of materials. Insome embodiments, the variable volume pouch can comprise a naturalmaterial, a synthetic material, a man-made material, a polymer,composite material, an elastic material, an inelastic material and/orany other desired material. In some embodiments, and as depicted inFIGS. 4A and 4B, the variable volume pouch 400 can comprise a wovenmaterial. Advantageously, a woven material can allow expansion of thevariable volume pouch 400 to a desired maximum size.

The variable volume pouch 400 can comprise a variety of sizes. In someembodiments, the variable volume pouch 400 can be sized to allowplacement between two vertebrae. Specifically, in some embodiments, thevariable volume pouch 400 can be sized to fit between two vertebrae andspecifically between the end plates of two vertebrae.

The Intervertebral Cage Apparatus

Some embodiments relate to an intervertebral cage apparatus. FIG. 5Adepicts a perspective view of one embodiment of the intervertebral cageapparatus 500. The intervertebral cage apparatus 500 comprises theintervertebral cage 100. The intervertebral cage 100 depicted in FIG. 5Acomprises the features of the intervertebral cage 100 depicted in FIG.1A, including a body 102 having a proximal end 110 and a distal end 112.The body 102 defines a longitudinal axis 104 extending down the centerof the body 102 and between the proximal end 110 and the distal end 112.The body 102 of the intervertebral cage 100 depicted in FIG. 5A furthercomprises a top 120 and a bottom 122 and defines a vertical axis 108extending between the top 120 and the bottom 122 and perpendicular tothe longitudinal axis 104. The body 102 of the intervertebral cage 300further defines a lateral axis 106 which extends perpendicular to boththe longitudinal axis 104 and the vertical axis 108.

The body 102 of the intervertebral cage 100 depicted in FIG. 5A furthercomprises a plurality of segments 116 joined by flexible connectors 118.The segments 116 and flexible connectors 118 of the body 102 define aninternal volume 126 of the body 102.

As seen in FIG. 5A, the intervertebral cage apparatus 500 furtherincludes the variable volume pouch 400 located within the internalvolume 126 of the intervertebral cage 100. In some embodiments, thevariable volume pouch 400 can be affixed to all or portions of theintervertebral cage 100. In some embodiments, for example, the variablevolume pouch 400 can be inserted into the internal volume 126 of theintervertebral cage 100 such that the second end 404 of the variablevolume pouch 400 is proximate to the distal end 112 of theintervertebral cage 100 and the first end 402 is proximate to theproximal end 110 of the intervertebral cage 100. In some advantageousembodiments, in which the first end 402 is proximate to the proximal end110 of the intervertebral cage 100, the opening 406 of the variablevolume pouch 400 is located proximate to the proximate aperture 124 ofthe body 102 of the intervertebral cage 100. Thus, in some embodiments,the variable volume pouch 400 can be inserted into the internal volume126 of the body 102 of the intervertebral cage 100 through the proximalaperture 124. In such an embodiment, after the variable volume pouch 400is inserted into the internal volume 126 of the body 102 via theproximal aperture 124, the variable volume pouch 400 can be partially orcompletely affixed to the body 102 of the intervertebral cage 100. Insome embodiments, the variable volume pouch 400 can be affixed to thebody 102 of the intervertebral cage 100 such that the expansion of thevariable volume pouch 400 can result in the deployment of the body 102of the intervertebral cage 100 and in some embodiments, the affixationof the variable volume pouch 400 to the body 102 of the intervertebralcage 100 can result in the expansion of the variable volume pouch 400when the body 102 of the intervertebral cage 100 is deployed.

In some embodiments, the intervertebral cage apparatus 500 can furthercomprise a plug 502. The plug 502 can be configured to sealingly fitwithin the proximal aperture 124 to seal the proximal aperture, tosecure the first end 402 of the variable volume pouch 400 to theproximal end 110 of the intervertebral cage 100, and to seal the opening406 of the variable volume pouch. In some embodiments, the plug 502 canbe further configured to facilitate in the deployment of theintervertebral cage 100. The plug 502 can comprise a variety of shapesand sizes, and can be made from a variety of materials, including, forexample, all of the materials from which the intervertebral cage 100 canbe made.

In some embodiments, the plug 502 can comprise a proximal shaft 504 anda distal head 506. The proximal shaft 504 can comprise a variety ofshapes and sizes. In some embodiments, the proximal shaft 504 can besized and shaped to seal the proximal aperture 124, and specifically canbe sized and shaped with larger dimensions than the proximal aperture124. In some embodiments, the configuration of the proximal shaft 504with dimensions larger than the dimensions of the proximal aperture 124can facilitate the retention of the plug 502 in the proximal aperture124.

In some embodiments, the distal head 506 can comprise a variety ofshapes and sizes. In some embodiments, the distal head 506 can beconical shaped, having a distal base 508, and extending towards the apexin the direction of the proximal shaft 504. The distal head 506 can beshaped, in some embodiments, to facilitate in deploying theintervertebral cage 100.

FIG. 6A depicts one embodiment of the intervertebral cage apparatus 500in a deployed configuration in which the body 102 of the intervertebralcage 100 is deployed and in which the variable volume pouch 400 is inits expanded configuration. As seen in FIG. 6A, the variable volumepouch 400 in its expanded configuration fills and/or substantially fillsthe internal volume 126 of the intervertebral cage 100.

FIG. 6B is a cutaway top-view of the intervertebral cage apparatus 500in a deployed configuration. As seen in FIG. 6B, the proximal shaft 504of the plug 502 is located in the proximal aperture 124 of the body 102of the intervertebral cage 100. As also seen in FIG. 6B, the proximalshaft 504 of the plug has expanded the diameter of the proximal aperture124, and is thereby secured within the proximal aperture 124. As alsoseen in FIG. 6B, the plug 502 is positioned within the proximal aperture124 such that a portion of the first end 402 of the variable volumepouch 400 is between the proximal shaft 504 and the wall of the proximalaperture, thereby securing the variable volume pouch 400.

FIG. 6B further depicts the distal head 506 of the plug 502 extendinginto the internal volume 126 of the intervertebral cage 100. As seen inFIG. 6B, the distal head 506 is engaging portion of the body 102, tothereby bias the body 102 of the intervertebral cage 100 towards adeployed configuration.

In some embodiments, in which the plug 502 is used in connection withthe intervertebral cage apparatus 500, the variable volume pouch 400 canbe inserted into the intervertebral cage 100 through the proximalaperture 124 and positioned such that the first end 402 of the variablevolume pouch 400 and the opening 406 are proximate to the proximalaperture 124. In some embodiments, the variable volume pouch 400 can beat least partially affixed to the intervertebral cage 100. After thevariable volume pouch 400 is inserted into the intervertebral cage 100,positioned, and if desired, at least partially affixed to theintervertebral cage 100, the variable volume pouch can be filled and/orthe intervertebral cage 100 can be deployed.

In some embodiments, the plug 502 can be inserted into theintervertebral cage 100, and partially into the internal volume 126 ofthe intervertebral cage, by inserting the plug 502 into and through theproximal aperture 124 from the proximal end 110 of the intervertebralcage 100 towards the distal end 112 of the intervertebral cage 100.Advantageously, the insertion of the plug 502 can affix the variablevolume pouch 400 to the proximal end 110 of the intervertebral cage, canseal the opening 406 of the variable volume pouch 400, and can assist inthe deployment of the intervertebral cage 100.

In some embodiments, in which the plug 502, and specifically in whichthe distal head 506 and the proximal shaft 504 have a larger diameterthan the proximal aperture 124, the insertion of the plug into andthrough the proximal aperture 124 from the proximal end 110 of theintervertebral cage 100 towards the distal end 112 of the intervertebralcage 100 can result in the deformation of the proximal aperture 124. Insome embodiments, all or portions of the proximal aperture 124 maypartially or completely elastically rebound after the insertion of theplug 502, and in some embodiments, all or portions of the proximalaperture 124 may not elastically rebound after the insertion of the plug502.

FIG. 7 depicts an alternative embodiment of the intervertebral cageapparatus 500. Specifically, FIG. 7 depicts an embodiment of theintervertebral cage apparatus 500 comprising a variable volume pouch 400shown in this figure in its expanded state, and the intervertebral cage300 comprising a lateral split 302 shown in its fully deployedconfiguration. As seen in FIG. 7, the intervertebral cage 300 isdeployed in both the lateral direction 106 as measured along the lateralaxis 106 and deployed in the vertical direction as measured along thevertical axis 108. As seen in FIG. 7, the variable volume pouch 400substantially fills and/or fills the internal volume 126 of theintervertebral cage 300.

The Deployment System

Some embodiments relate to systems and devices for the insertion anddeployment of an intervertebral cage apparatus 500 and/or of theintervertebral cage 100, 300. FIG. 8 depicts one embodiment of insertiondeployment system 800. As seen in FIG. 8, the deployment system 800 caninclude a deployment tool 802. The deployment tool 802 can be configuredto facilitate in the insertion of the intervertebral cage apparatus 500and/or the intervertebral cage 100, 300 and to control the deployment ofthe intervertebral cage apparatus 500 and/or the intervertebral cage100, 300.

The deployment tool 802 can comprise a variety of shapes and sizes andcan comprise a variety of features. In some embodiments, for example,the deployment tool 802 can be a mechanical device, an electromechanicaldevice and/or an electrical device. In some embodiments, for example,the deployment tool 802 can be manually operated, can be electricallycontrolled, and/or can be controlled using any other desired controltechnique. As depicted in FIG. 8, the deployment tool 802 comprises acontrol interface 804. The control interface 804 can be configured toallow a user to control the deployment tool 802 and the insertion and/ordeployment of the intervertebral cage apparatus 500 and/or theintervertebral cage 100, 300. In some embodiments, for example, thecontrol interface can comprise any feature, system, and/or moduleconfigured to receive user input and use that input to effect thedeployment of the intervertebral cage apparatus 500 and/or theintervertebral cage 100, 300. As depicted in FIG. 8, the controlinterface 804 can comprise a simple manual control configured to apply aforce to one end of a deployment cable 806.

In some embodiments in which the deployment tool 802 can be used inconnection with other features to insert the intervertebral cage 100,300. In such embodiments, the deployment tool 802 can be used with arigid shaft. In one embodiment, the rigid shaft can comprise a proximalend that is affixed to the deployment tool 802 and a distal endconfigured to engage with the intervertebral cage 100, 300. In someembodiments, these features configured to engage with the intervertebralcage 100, 300 and located at the distal end of the rigid shaft cancomprise one or several prongs (not shown) configured to engage portionsof the intervertebral cage 100, 300. In some embodiments, the featuresconfigured to selectively affix the intervertebral cage 100, 300 to thedeployment tool 802, can allow the manipulation and movement of theintervertebral cage 100, 300 along and/or about any of the axes 104,106, 108 of the intervertebral cage 100, 300.

In some embodiments, the rigid shaft can be configured to allow thepassage of the deployment cable 806 from the deployment tool 802 to theintervertebral cage 100, 300. In some embodiments, the deployment cable806 can pass along the rigid shaft and/or through the rigid shaft fromthe deployment tool 802 to the intervertebral cage 100, 300. The passingof the deployment cable 806 from the deployment tool 802 to theintervertebral cage 100, 300 can be facilitated by one or severalchannels located within the rigid shaft. In some embodiments, theserigid channels can be located on an exterior surface of the rigid shaft,and or located within the rigid shaft. In some embodiments, the channelscan extend the entire length of the rigid shaft, and/or along portionsof the rigid shaft.

In some embodiments in which the deployment tool 802 is only used fordeployment of the intervertebral cage 100, 300 a separate insertion tooland/or tools can be used in the insertion of the intervertebral cage100, 300. Some embodiments of such an insertion tool and/or implantationtool can be found in U.S. Publication No. 2012/0083887 published on Apr.5, 2012 which is incorporated herein in its entirety by reference. Thispublication is attached in Appendix A, and constitutes part of thepresent application.

The deployment cable 806 can be configured to transfer a force from thedeployment tool 802 to the intervertebral cage apparatus 500 and/or theintervertebral cage 100, 300. In some embodiments, the deployment cable806 can be configured to facilitate the deployment of the intervertebralcage apparatus 500 and/or the intervertebral cage 100, 300 and/or tofacilitate in maintaining the intervertebral cage apparatus 500 and/orthe intervertebral cage 100, 300 in a deployed configuration. In someembodiments, the deployment cable 806 can be configured for use as amarker, and specifically, can be used as a marker to indicate theposition of the intervertebral cage 100, 300 and/or to determine whetherand to what extent the intervertebral cage 100, 300 has been deployed.In some embodiments, for example, the deployment cable 806 can includeregularly spaced features that can allow determination of whether and/orto what extent the intervertebral cage 100, 300 is deployed by allowingthe determination of the length of the deployment cable 806 within theintervertebral cage 100, 300 As the deployment of the intervertebralcage 100, 300 may, in some embodiments, change a dimension of theintervertebral cage 100, 300 the determination of the length of theportion of the deployment cable 806 located within the intervertebralcage can facilitate in determining whether and/or to what extent theintervertebral cage 100, 300 is deployed.

The deployment cable 806 can comprise a variety of shapes and sizes andcan be made from a variety of materials. In some embodiments, thedeployment cable 806 can comprise any shape and size and can be madefrom any material capable of applying and withstanding the forcesnecessary to deploy the intervertebral cage apparatus 500 and/or theintervertebral cage 100, 300.

As depicted in FIG. 8, the deployment cable 806 comprises a first end808 and a second end 810. In some embodiments, the first end 808 cancomprise an attachment feature 812. The attachment feature 812 can beany feature configured to allow the attachment of the deployment cable806 to a portion of the intervertebral cage 100, 300 and/or to preventthe movement of the deployment cable 806 in one or several specifieddirections relative to the intervertebral cage 100, 300.

The attachment feature 812 can comprise a variety of shapes and sizesand can be made from a variety of materials. In one embodiment, forexample, the attachment feature 812 can comprise a shape and/or sizethat allows the attachment feature 812 to engage a portion of theintervertebral cage 100, 300 and thereby restrict the movement of thedeployment cable 806 relative to the intervertebral cage 100, 300. Asspecifically seen in FIG. 8, in some embodiments, the attachment featurecan comprise a spherical feature located at the first end 808 of thedeployment cable 806.

In some embodiments, the deployment cable 806 can comprise a breakagepoint (not shown). In some embodiments, the breakage point can be aportion of the deployment cable 806 that is configured to sever, break,and/or separate when a force threshold is exceeded. In some embodiments,the force threshold for the breakage point can be below the forcethreshold that would cause other portions and/or features such as, forexample, the attachment feature 812 and/or the locking feature 814 ofthe deployment cable 806 to break or fail. In some embodiments, thebreakage point can be positioned between, for example, between thelocking feature 814 and the second end 810 of the deployment cable 806.Advantageously, as the application of a force above the force thresholdresults in the breakage of the deployment cable 806 at the breakagepoint, such positioning of the breakage point can eliminate the need tocut the deployment cable 806 after the intervertebral cage 100, 300 hasbeen deployed.

As also seen in FIG. 8, the second end 810 of the deployment cable 806can be connected to a portion of the deployment tool 802. As furtherseen in FIG. 8, in some embodiments, the deployment cable 806 furthercomprises a locking feature 814 that can be, for example, located at anyposition along the deployment cable, and in some embodiments, locatedbetween the attachment feature 812 and the second end 810 of thedeployment cable 806. The locking feature 814 can be configured to allowa user to lock and/or secure the intervertebral cage 100, 300 in adeployed configuration. In some embodiments, the locking feature 814 cancomprise the size and/or shape configured to interact with a portion ofthe intervertebral cage 100, 300 and thereby prevent the intervertebralcage 100, 300 from returning to an undeployed configuration after theintervertebral cage 100, 300 has been deployed.

In some embodiments, for example, the distance between the attachmentfeature 812 and the locking feature 814 can vary. Specifically, forexample, the distance between the attachment feature 812 and the lockingfeature 814 can vary based on the size of the intervertebral cage 100,300, the distance that the deployment cable 806 must be moved before theintervertebral cage 100, 300 deploys, and/or any other desiredparameters.

FIGS. 9 and 10 depict perspective views of one embodiment of anintervertebral cage apparatus 900. Specifically, FIG. 9 depicts oneembodiment of the intervertebral cage apparatus 900 in an undeployedconfiguration and FIG. 10 depicts a perspective view of one embodimentof an intervertebral cage apparatus 900 in a deployed configuration. Asseen in FIGS. 9 and 10, the intervertebral cage 100 can be configuredfor use with a deployment cable 806. In some embodiments, for example,the intervertebral cage 100 can comprises one or several opening and/orone or several channels configured to receive, direct, and/or hold aportion of the deployment cable. These openings can comprise a varietyof shapes and sizes, and can be located on any desired portion of theintervertebral cage. In some embodiments, the size and shape of theopenings can be determined by the size and shape of featuresaccommodated by the openings, such as, for example, the deployment cable806, the attachment feature 812, and/or the locking feature 814.Specifically, for example, the intervertebral cage 100 can comprise oneor several distal openings 902 located proximate to the distal end 112of the body 102 of the intervertebral cage 100 and a first and/or secondproximal opening 906, 908 located proximate to the proximal end 110 ofthe intervertebral cage 100.

The distal opening(s) 902, the first proximal opening 906, and thesecond proximal opening 908 can be configured to receive a portion ofthe deployment cable 806. In some embodiments, for example, all or someof the distal opening(s) 902, the first proximal opening 906 and/or thesecond proximal opening 908 can guide the deployment cable 806 into andout of a portion of the intervertebral cage 100. In some embodiments,these openings 902, 906, 908 can be connected to one or several channelsthat pass through all or portions of the intervertebral cage 100. Thus,in some embodiments, the deployment cable may enter into theintervertebral cage 100 through the first proximal opening 906, andafter passing through all or a portion of the intervertebral cage 100,the deployment cable 806 may then exit the channel inside theintervertebral cage 100 via another opening such as, for example, thedistal opening 902 and/or the second proximal opening 908.

As further seen in FIG. 9, in some embodiments, the deployment cable 806can pass through the internal volume 126 of the body 102 of theintervertebral cage 100. Specifically, in some embodiments, all orportions of the deployment cable 806 can extend from a first proximalopening 906 to a distal opening 902 and/or from a distal opening 902 toa second proximal opening 908 alongside an inner surface of the cage100.

In some embodiments, a plurality of deployment cables 806 can be used inconnection with a single intervertebral cage 100, 300. In someembodiments, the number of deployment cables 806 can be determined bythe desired type of deployment. Thus, in some embodiments, the moredeployment cables 806 may be used to achieve a more complex deploymentmotion.

FIG. 11 depicts one embodiment using a plurality of deployment cables.Specifically, FIG. 11 depicts a further embodiment of the intervertebralcage apparatus 1100. As seen in FIG. 11, the intervertebral cageapparatus 1100 comprises the intervertebral cage 300 comprising alateral split 302. As further seen in FIG. 11, the intervertebral cage300 further comprises a lower first proximal opening 1102, a lowersecond proximal opening 1104, an upper first proximal opening 1106, anupper second proximal opening 1108, a lower distal opening 1110, and anupper distal opening 1112.

As also seen in FIG. 11, the intervertebral cage apparatus 1100comprises two deployment cables 806. One of the deployment cables 806depicted in FIG. 11 inserts through the lower first proximal opening1102 and then passes through the variable volume pouch 400 where itexits through one of at least one lower distal opening 1110 before againpassing through the variable volume pouch and to the lower secondproximal opening 1104. This path of the deployment cable 806 secures aportion of the variable volume pouch 400 to the intervertebral cage 300and specifically to the bottom portion 310 of the intervertebral cage300.

As also seen in FIG. 11, the other deployment cable 806 passes throughthe upper first proximal opening 1106 and then through the variablevolume pouch to at least one of the upper distal openings 1112 beforeagain passing through the variable volume pouch and to the upper secondproximal opening 1108. Similar to the deployment cable 806 passingthrough the lower openings 1102, 1104, 1110, the deployment cable 806passing through the upper openings 1106, 1108, 1112, secures a portionof the variable volume pouch 400 to the intervertebral cage 300 andspecifically to the top portion 308 of the intervertebral cage 300.Advantageously, the securement of the variable volume pouch 400 to thetop portion 308 and the bottom portion 310 allows use of a variablevolume pouch 400 to at least partially vertically deploy theintervertebral cage 300 with respect to the vertical axis 108 by fillingthe internal portion of the variable volume pouch 400.

While FIG. 11 depicts an embodiment in which two deployment cables 806are used and showing specific positions for the openings 1102, 1104,1106, 1108, 1110, 1112, a person of skill in the art will recognize thatany number of deployment cables 806 can be used in connection with theintervertebral cage 300 and that a wide variety of positions for theopenings can be used.

Methods of Using an Intervertebral Cage Apparatus

FIG. 12 is a flowchart illustrating one embodiment of process 1200 forusing the intervertebral cage 100, 300 and/or the intervertebral cageapparatus 500, 1100. The process begins at block 1210 wherein theintervertebral disc space is prepared, for example, by removing aportion of the annulus, evacuating the nucleus, and then removing thecartilaginous endplates.

After the intervertebral disc space is prepared, the process 1200proceeds to block 1212 wherein the intervertebral cage 100, 300 isplaced into the intervertebral disc space. In one embodiment, theintervertebral cage 100, 300 is rotated about its longitudinal axis 104and placed in the intervertebral disc space such that the vertical axis108 of the body 102 of the intervertebral cage 100, 300 is parallel tothe vertebral endplates.

The process 1200 proceeds to block 1214 wherein the intervertebral cage100, 300 is rotated 90 degrees about its longitudinal axis 104. Afterthe rotation of the intervertebral cage 100, 300, the top 120 and thebottom 122 contact the vertebral endplates. In some embodiments, inwhich the distance between the top 120 and the bottom 122 of the body102 of the intervertebral cage 100, 300 is larger than the width of thebody 102 of the intervertebral cage 100, 300 as measured parallel to thelateral axis 106, the 90 degree rotation of the body 102 along itslongitudinal axis 104 increases the height of the intervertebral discspace.

After the intervertebral cage 100, 300 is rotated 90 degrees about itslongitudinal axis 104, the process 1200 proceeds to block 1216 whereinthe intervertebral cage 100, 300 is expanded to increase the internalvolume 126 defined by the body 102, and in some embodiments, defined bythe segments 116 and flexible connectors 118 forming the body 102. Insome embodiments, the expansion of the intervertebral cage 100, 300 canproceed as outlined in step 1406 as depicted in FIG. 14.

In some embodiments, the body 102 is expanded until the body 102 attainsa deployed configuration. In some embodiments, for example, in which athe intervertebral cage 100, 300 is used in connection with a deploymenttool 802, the actuation of the deployment tool 802 can cause thedeployment of the intervertebral cage 100, 300 and thereby the expansionof the intervertebral cage 100, 300 and the expansion of the internalvolume 126 of the intervertebral cage 100, 300. In some embodiments inwhich the intervertebral cage 100, 300 comprises a body 102 made of amemory material such as, for example, PEEK Altera™, the intervertebralcage 100, 300 can be deployed by triggering the memory material suchthat the intervertebral cage 100, 300 transforms from the undeployed,second position to the deployed, first position. In some embodiments,triggering can be temperature induced, stress induced, electricallyand/or mechanically induced, chemically induced, and/or through anyother triggering mechanism. In some specific embodiments, the triggeringcan be induced when a threshold temperature of the intervertebral cage100, 300 is exceeded, or when a stress threshold for the intervertebralcage 100, 300 is surpassed.

After the intervertebral device is expanded to increase the internalvolume 126 defined by the body 102, the process 1200 can, in someembodiments, proceed to block 1218 wherein the intervertebral device islocked in a deployed configuration with a locking mechanism such as, forexample, a deployment cable 806. Although the process 1200 can, in someembodiments, include block 1218, the steps of this block can be omittedand the process 1200 can proceed to block 1220.

The process 1200 can then proceed to block 1220, wherein the internalvolume 126 of the body 102 of the intervertebral cage 100, 300 is filledwith bone graft material to permit bone fusion between adjacentvertebrae. In some embodiments, the internal volume 126 of the body 102of the intervertebral cage 100, 300 can be filled via the proximalaperture 124 located in the proximal end 110 of the body 102 of theintervertebral cage 100, 300.

A person of skill in the art will recognize that the steps of theaforementioned process can be performed in the same order, or in adifferent order. A person of skill in the art will further recognizethat the process 1200 can include more or fewer steps than thoseoutlined above.

FIG. 13 is a flow chart illustrating one embodiment of the process 1300for using an intervertebral cage apparatus 500. In some embodiments,parts of the process 1300 can be performed before insertion of theintervertebral cage apparatus 500 into an intervertebral space, and insome embodiments, parts of the process 1300 can be performed afterinsertion of the intervertebral cage apparatus into an intervertebralspace.

The process 1300 begins at block 1302 wherein the variable volume pouch400 is inserted into the intervertebral cage 100, 300. In someembodiments, for example, the insertion of the variable volume pouch 400into the intervertebral cage 100, 300 can be performed using a varietyof tools and techniques. In some embodiments, for example, the variablevolume pouch can be inserted into the intervertebral cage 100, 300 viathe proximal aperture 124 in the proximal end 110 of the body 102 of theintervertebral cage 100, 300. In some embodiments, the variable volumepouch 400 can be inserted into the internal volume 126 of theintervertebral cage 100, 300 via the proximal aperture 124 located inthe proximal end 110 of the intervertebral cage 100, 300. In someembodiments, the variable volume pouch 400 can be pre-inserted into theintervertebral cage 100, 300, and the process 1300 can begin at a blockother than block 1302.

After the variable volume pouch 400 has been inserted into theintervertebral cage 100, 300, the process 1300 then proceeds to block1304 wherein the opening 406 of the variable volume pouch 400 ispositioned proximate to the proximal aperture 124 of the intervertebralcage 100, 300. In some embodiments, the positioning of the opening 406of the variable volume pouch 400 proximate to the proximal aperture 124of the intervertebral cage 100, 300 can be achieved, for example, byinserting the second end 404 of the variable volume pouch 400 throughthe proximal aperture 124 before inserting the first end 402 of thevariable volume pouch 400 through the proximal aperture 124. Byfollowing this insertion procedure, and thereby inserting the second end404 of the variable volume pouch 400 through the proximal aperture 124first, the opening 406 of the variable volume pouch 400 which is locatedat the first end 402 of the variable volume pouch 400 can be easilypositioned proximate to the proximal aperture 124 of the intervertebralcage 100, 300. In some embodiments in which the variable volume pouch400 is pre-inserted into the intervertebral cage 100, 300, the process1300 can begin at block 1304. In some embodiments, the opening 406 ofthe variable volume pouch 400 can be pre-positioned proximate to theproximal aperture 124 of the intervertebral cage 100, 300, and theprocess 1300 can begin at a block other than block 1304.

After the opening 406 of the variable volume pouch 400 has beenpositioned proximate to the proximal aperture 124 of the intervertebralcage 100, 300, the process 1300 proceeds to block 1306 wherein thevariable volume pouch 400 is affixed to the intervertebral cage 100,300. In some embodiments, for example, the variable volume pouch 400 canbe affixed to all or portions of the intervertebral cage 100, 300 andspecifically to all or portions of the body 102 of the intervertebralcage 100, 300. In some embodiments, for example, the variable volumepouch 400 can be affixed to the body 102 of the intervertebral cage 100,300 along the portions of the body 102 defining the internal volume 126.Specifically, portions of the variable volume pouch 400 can be affixedto the segments 116 and flexible connectors 118 that constitute the body102.

In some embodiments, the variable volume pouch 400 can be affixed to thebody 102 of the intervertebral cage 100, 300 with features located onthe body 102 of the intervertebral cage 100, 300 such as, for example,one or several fasteners, one or several hooks, one or several snaps,one or several adhesive regions, and/or any other desired featurelocated on either or both of the variable volume pouch 400 and the body102 of the intervertebral cage 100, 300. In some embodiments, forexample, the variable volume pouch 400 can be affixed to theintervertebral cage 100, 300 through additional features that are not anintegral part of either the variable volume pouch 400 or the body 102 ofthe intervertebral cage 100, 300. In some embodiments, these featurescan include, for example, one or several deployment cables 806. In someembodiments, for example, the deployment cable 806 can be fused to affixthe variable volume pouch 400 to the intervertebral cage 100, 300. Insome specific embodiments, the deployment cable 806 can be insertedthrough a portion of the intervertebral cage 100, 300 such as, forexample, the body 102, be threaded through a portion of the variablevolume pouch 400, and then again be inserted through a portion of theintervertebral cage 100, 300. In some embodiments, the passing of thedeployment cable 806 through portions of the intervertebral cage 100,300 and through portions of the variable volume pouch 400 can secure thevariable volume pouch 400 to the intervertebral cage 100, 300.

In some embodiments, the variable volume pouch 400 can be connected tothe intervertebral cage 100, 300 along the entire perimeter of theinternal volume 126, and in some embodiments, the variable volume pouch400 can be connected to the intervertebral cage 100, 300 at discretepoints. In some embodiments, the variable volume pouch 400 can beconnected to the intervertebral cage 100 at one point, two points, threepoints, four points, five points, six points, eight points, 10 points,20 points, 50 points, or at any other or intermediate number of points.In some embodiments in which the variable volume pouch 400 ispre-inserted into the intervertebral cage 100, 300 and in which theopening 406 of the variable volume pouch 400 has been pre-positionedproximate to the proximal aperture 124 of the intervertebral cage 100,300, the process 1300 can begin a block 1306. In some embodiments, thevariable volume pouch 400 can be pre-affixed to the intervertebral cage100, 300, and the process 1300 can begin at a block other than block1306. In some embodiments in which the assembly of the intervertebralcage apparatus 500 is temporally separated from the use of theintervertebral cage apparatus 500, the process 1300 can terminate withblock 1306.

In some embodiments of the process 1300 in which the assembly of theintervertebral cage apparatus 500 is temporally proximate to the use ofthe intervertebral cage apparatus 500, after the variable volume pouch400 is affixed to the intervertebral cage 100, 300, the process 1300 canproceed to block 1308 wherein the intervertebral cage 100, 300 isdeployed. In some embodiments, block 1308 can be preceded by processesfor preparing the intervertebral space and for inserting theintervertebral cage apparatus 500. In some embodiments, these processescan include, for example, some or all of the steps of the process 1200depicted in FIG. 12.

In some embodiments, the intervertebral cage 100, 300 can be deployedusing any desired deployment technique and/or deployment device. In somespecific embodiments, for example, the intervertebral cage can bedeployed using a deployment system 800 comprising a deployment tool 802and a deployment cable 806. In some embodiments, deployment of theintervertebral cage 100, 300 can result in a change in the dimensions ofthe intervertebral cage 100, 300 as measured along one or more of thelongitudinal axis 104, the lateral axis 106, and/or the vertical axis108.

After the intervertebral cage 100, 300 is deployed, the process 1300proceeds to block 1310 wherein the variable volume pouch 400 is filled.In some embodiments, for example, the variable volume pouch 400 can befilled via the opening 406 at a variable volume pouch 400. In someembodiments, the variable volume pouch 400 can be filled via the opening406 of the variable volume pouch and the proximal aperture 126 locatedin the proximal end 110 of the intervertebral cage 100, 300. In someembodiments, the variable volume pouch can be filled with, for example,a gaseous material, a liquid material, and/or a solid material. In someembodiments, the variable volume pouch 400 can be filled with a graphmaterial which can comprise, for example, a solid material andspecifically, a plurality of pieces of solid material. In someembodiments, these materials can comprise bone fragments and/or piecesof bones, and/or any biocompatible material.

In some embodiments, the variable volume pouch 400 can be filled with adesired amount of film material. In some embodiments, the desired amountof film material can be based on the desired size of the variable volumepouch 400 in its expanded state. Thus, in some embodiments, the desiredsize of the expanded state of the variable volume pouch 400 candetermine the amount of film material. After the variable volume pouch400 has been filled, steps can be taken to maintain the fill materialwithin the variable volume pouch 400. In some embodiments, these stepscan include, for example, sealing the opening 406, closing the opening406, plugging the opening 406, or any other action that would preventthe film material from emptying out of the variable volume pouch 400.

FIG. 14 is a flowchart illustrating one embodiment of the process 1400for preparing and/or using the intervertebral cage apparatus 900, 1100,which may or may not have a variable volume pouch 400. In someembodiments, the process 1400 can be performed before insertion of theintervertebral cage apparatus 900, 1100 into an intervertebral space,and in some embodiments, the process 1400 can be performed afterinsertion of the intervertebral cage apparatus into an intervertebralspace.

The process 1400 begins at block 1402 wherein the deployment cable 806is inserted through the proximal end 110 of the intervertebral cage 100,300. In some embodiments, for example, the deployment cable 806 isinserted through the proximal end 110 of the intervertebral cage 100,300 by inserting the deployment cable 806 through a first proximalopening 906, 1104, 1108. In some embodiments, the deployment cable 806that is inserted through the first proximal opening 906, 1104, 1108passes through the proximal end 110 of the intervertebral cage 100, 300and into the internal volume 126 of the intervertebral cage 100, 300. Insome embodiments, the deployment cable 806 that is inserted into thefirst proximal opening 906, 1104, 1108 passes into a channel and passesthrough all or portions of the intervertebral cage 100, 300. In someembodiments, the deployment cable 806 can be pre-inserted through theproximal end 110 of the intervertebral cage 100, 300, and the process1400 can begin at a block other than block 1402. In some embodiments,the deployment cable 806 need not be inserted through the proximal end110 of the intervertebral cage 100, 300, but is rather simply attachedor affixed at or near the proximal end 110 of the intervertebral cage100, 300.

After the deployment cable 806 is inserted through or affixed to theproximal end 110 of the intervertebral cage 100, 300, the process 1300moves to block 1304 and the deployment cable 806 is inserted through thedistal end 112 of the intervertebral cage 100, 300. In some embodiments,the deployment cable 806 can be inserted into the distal end 112 of theintervertebral cage 100, 300 by inserting the deployment cable 806 intoand/or through a distal opening 902, 1110, 1112. In some embodiments, inwhich the deployment cable 806 passed through the proximal end 1110 ofthe intervertebral cage 100, 300 and into the internal volume 126, thedeployment cable 806 can be inserted into the distal end 112 via thedistal opening 902, 1110, 1112 from the internal volume 126. In someembodiments, in which the deployment cable 806 passes through a channelfrom the first proximal opening 906, 1104, 1108, the deployment cable806 may be inserted through the distal end 1112 of the intervertebralcage 100, 300 by passing through a channel that travels through thedistal end of the intervertebral cage. In some embodiments in which thedeployment cable 806 has been pre-inserted through the proximal end 110of the intervertebral cage 100, 300, the process 1400 can begin at block1404. In some embodiments, the deployment cable 806 can be pre-insertedthrough the distal end 112 of the intervertebral cage 100, 300, and theprocess 1400 can begin at a block other than block 1404. In someembodiments in which the assembly of the intervertebral cage apparatus900, 1100 is temporally separated from the use of the intervertebralcage apparatus 900, 1100, the process 1400 can terminate with block1404.

In some embodiments, after the deployment cable 806 is inserted throughthe distal end 112 of the intervertebral cage 100, 300 the deploymentcable 806 can be returned to the proximal end 110 of the intervertebralcage 100, 300. In some embodiments, the deployment cable 806 can returnto the proximal end 110 of the intervertebral cage 100, 300 by insertingthe deployment cable 806 into and/or through a second distal opening902, 1110, 1112. After the deployment cable 806 has been inserted intoand/or through the second distal opening 902, 1110, 1112, the deploymentcable 806 passes through the distal end 112 of the intervertebral cage100, 300 and into the internal volume 126 of the intervertebral cage100, 300. In some embodiments, the deployment cable 806 that is insertedinto the distal opening 902, 1110, 1112 passes into a channel and passesthrough all or portions of the intervertebral cage 100, 300.

After the deployment cable 806 returns to the proximal end 110 of theintervertebral cage 100, 300, the deployment cable 806 can be insertedthrough the proximal end 110 of the intervertebral cage 100, 300 byinserting the deployment cable 806 through a second proximal opening908, 1102, 1106. In some embodiments, the deployment cable 806 that isinserted through the second proximal opening 908, 1102, 1106 passes fromthe internal volume 126 of the intervertebral cage 100, 300 and throughthe proximal end 110 of the intervertebral cage 100, 300. In someembodiments, the deployment cable 806 can be pre-inserted through theproximal end 110 of the intervertebral cage 100, 300. In someembodiments, the deployment cable 806 need not be inserted through theproximal end 110 of the intervertebral cage 100, 300, but can rather besimply attached or affixed at or near the proximal end 110 of theintervertebral cage 100, 300.

After the deployment cable 806 is inserted through or affixed to theproximal end 110 of the intervertebral cage 100, 300, the deploymentcable 806 can be connected to the deployment tool 802, which can then beused to deploy the intervertebral cage 100, 300.

In some embodiments of the process 1400 in which the assembly of theintervertebral cage apparatus 900, 1100 is temporally proximate to theuse of the intervertebral cage apparatus 900, 1100, the process 1400proceeds to block 1406 wherein the intervertebral cage 100, 300 isdeployed by applying a force to the intervertebral cage 100, 300 via thedeployment cable 806. The force that is applied to the intervertebralcage 100, 300 via the deployment cable 806 can be generated using avariety of tools and/or techniques. In some embodiments, for example, inwhich the deployment cable 806 is part of an insertion system 800including a deployment tool 802, the force can be applied to theintervertebral cage 100, 300 via the deployment cable 806 by using thecontrol interface 804 to tension the deployment cable 806. In someembodiments, and as the force is applied to the intervertebral cage 100,300 via the deployment cable 806, the user is provided feedback via thedeployment tool 802 to allow the user to understand the status of thedeployment. Specifically, in some embodiments, the deployment tool 802can be configured to provide user feedback indicating that the furtherapplication of force to the intervertebral cage 100, 300 will result inthe locking of the intervertebral cage 100, 300 in a deployedconfiguration. In some embodiments, for example, this feedback cancomprise an audible, visual, and/or tactile signal that indicates thatthe intervertebral cage 100, 300 is nearing the locked and/or deployedconfiguration. In some embodiments, block 1406 can be preceded byprocesses for preparing the intervertebral space and for inserting theintervertebral cage apparatus 900, 1100. In some embodiments, theseprocesses can include, for example, some or all of the steps of theprocess 1200 depicted in FIG. 12.

After the intervertebral cage 100, 300 is deployed by applying a forceto the intervertebral cage 100, 300 via the deployment cable 806, theprocess 1400 proceeds to block 1408 wherein the intervertebral cage 100,300 is locked in the deployed configuration. In some embodiments, inwhich the deployment cable 806 includes a locking feature 814, theintervertebral cage 100, 300 can be locked into the deployedconfiguration through the use of the locking feature 814 on thedeployment cable 806. In one specific embodiment of how the lockingfeature 814 could be used in connection with the intervertebral cage100, 300 to lock the intervertebral cage 100, 300 into a deployedconfiguration, the locking feature can comprise a member having adimension and/or diameter larger than the diameter of the deploymentcable 806. As the deployment cable 806 is retracted from the secondproximal opening 908, 1104, 1108 to deploy the intervertebral cage 100,300 the locking feature 814 can be moved through the proximal end 110 ofthe intervertebral cage 100, 300 and out the second proximal opening908, 1104, 1108. In some embodiments, in which a locking feature 814 isused to secure the intervertebral cage 100, 300 in a deployed and/orlocked configuration, the second proximal opening 908, 1104, 1108 can beconfigured to allow the locking feature 814 to pass through the proximalend 110 of the intervertebral cage 100, 300 and out the second proximalopening 908, 1104, 1108 but to prevent the locking feature 814 fromretracting through the second proximal opening 908, 1104, 1108 and backinto the proximal end 110 of the intervertebral cage 100, 300. Thus, insome embodiments, once the locking feature has been withdrawn from theproximal end 110 of the intervertebral cage 100, 300, via the secondproximal opening 908, 1104, 1108, the locking feature can engage withportions of the second proximal opening 908, 1104, 1108 to secure theintervertebral cage 100, 300 in a locked and/or deployed configuration.In some embodiments, after the intervertebral cage 100, 300 has beenlocked in the deployed configuration, the force threshold can beexceeded, and the deployment cable 806 can break at the breakage point.In some embodiments, after the intervertebral cage 100, 300 is in thelocked and/or deployed configuration, fill and/or graft material can beinserted into the internal volume 126 of the body 102 of theintervertebral cage 100, 300 via the proximal aperture 124.

A person of skill in the art will recognize that the process 1300 and1400 can include more or fewer steps than those outlined above. A personof skill in the art will further recognize that the above outlined stepsof processes 1300 and 1400 can be performed in any desired order, andcan include substeps or subprocesses. A person of skill in the art willfurther recognize that the specific methods of locking theintervertebral cage 100, 300 into a deployed configuration are notlimited to the specific embodiments enumerated herein, but that a widevariety of techniques and devices can be used to lock the intervertebralcage 100, 300 in a deployed and/or locked configuration. A person ofskill in the art will further recognize that the processes depicted inFIGS. 12, 13, and 14 can be combined, and that thus an intervertebralcage 100, 300 can be used with both the variable volume pouch 400 andthe deployment cable 806.

FIGS. 15A-15C are illustrations of an embodiment of an intervertebralcage apparatus 1500 which has a distal aperture 1502 located at a distalend of the body 102. With reference to FIG. 15A which is a perspectiveview of the intervertebral cage apparatus 1500, the distal aperture 1502is centered on the longitudinal axis 104 although in alternativeembodiments the aperture 1502 may be offset from the axis 104. In theillustrated embodiment, the distal aperture 1502 has a diameter lessthan that of the proximal aperture 124 and incorporates a couplingmechanism along its inner surface. In certain embodiments, the couplingmechanism takes the form of a bayonet mount. As shown in FIG. 15B whichis a cross-sectional view of the intervertebral cage apparatus 1500along Section A-A (shown in FIG. 15A), the distal aperture may have twoor more slots 1504 configured to receive two or more pins 1618 on adistal end of an implantation tool 1600 (described further with respectto FIGS. 16A-16C).

In the illustrated embodiment, the slots 1504 are “L-shaped” slotsformed along the inner surface of the distal aperture such that a firstportion of the slot extends from a proximal end of the distal aperture1502 distally to a location between the proximal end and distal end ofthe aperture 1502. As shown more clearly in FIG. 15C which is across-sectional view of the intervertebral cage apparatus 1500 alongSection B-B (shown in FIG. 15B), a second portion of the slot 1504 thenextends radially along the inner circumference of the inner surface ofthe distal aperture. The radial extension can be about 45 degrees toabout 135 degrees about the longitudinal axis 104. In the illustratedembodiment, the circumferential extension is about 90 degrees. In someembodiments, fewer or greater slots 1504 may be used. Additionally, insome embodiments, the slots 1504 may be placed such that the firstportion of the slot 1504 is centered on a plane formed by axes 104 and108. This could advantageously allow larger pins 1618 to be used(described further with respect to FIGS. 16A-16C) thereby reducinglocalized stresses and strains when deploying the device.

In other embodiments, slots 1504 of the distal aperture 1502 have nosecond portion such that the first portion runs entirely from a proximalend of the aperture 1502 to a distal end of the aperture 1502 allowingfor the pins 1618 to wholly pass therethrough. In such embodiments, thepins 1618 of the implantation tool can instead be used to engage andabut a distal face 1505 of the intervertebral cage apparatus 1500. Inyet other embodiments, the distal aperture 1502 has a diameter which isequal to, or greater than, the diameter of the proximal aperture 124.Furthermore, it is contemplated that in other embodiments, other typesof coupling mechanisms may be used to couple the implantation devicewith the body 102, such as, but not limited to, a press fit, aninterference fit, a friction fit, threads, and other coupling mechanismsknown in the art.

With reference to FIG. 15B, the proximal end 110 of the body 102 hascutouts 1506 configured to receive mating portions 1608 of animplantation tool 1600 shown in FIGS. 16A-16C. In the illustratedembodiment, two cutouts 1506 are located along the outer perimeter ofthe proximal end 110. In other embodiments, a different number ofcutouts 1506 can be used and is not limited to placement along the outerperimeter of the proximal end 110 of the body 102.

FIGS. 16A-16C are illustrations of an embodiment of an implantation tool1600 which can be used to convert the intervertebral cage apparatus 1500or other cage apparatuses described herein from an undeployed positionto a deployed position. With reference to FIG. 16A which is a partialcross-section of an embodiment of an implantation tool 1600, theimplantation tool 1600 has an outer cannula 1602 extending between aproximal end and a distal end of the tool 1600 and centered on luminaryaxis 1604. At the distal end of outer cannula 1602 is a connector 1606configured to contact the proximal end 110 of body 102. As shown moreclearly in FIG. 16C, which is a view of the distal end of theimplantation tool 1600, in one embodiment the connector 1606 hasdimensions which are equal to, or greater than, the dimensions of theproximal end 110 of body 102 such that the connector 1606 advantageouslydistributes any contact pressure over the entire surface area of theproximal end 110. In some embodiments, connector 1606 has two matingportions 1608 such as teeth protruding distally from the connector 1606which are configured to be inserted into and engage cutouts 1506 on theproximal end 110 of the body 102. In other embodiments, connector 1606may have fewer or greater mating portions 1608 depending on the amountof cutouts 1506 on the proximal end 110 of the body 102. Once engaged,the mating portions 1608 are configured to directly link the rotation ofthe body 102 with the rotation of the outer cannula 1602 therebyproviding a user of the implantation tool 1600 direct control of therotation of the body 102 during an implantation procedure.

At the proximal end of the outer cannula 1602 is a handle 1610configured to be held by a user of the implantation tool 1600. Thehandle 1610 is directly attached to the outer cannula 1602 such thatrotation of the handle 1610 also causes rotation of the outer cannula1602. As such, a user of the implantation tool 1600 can advantageouslycontrol the rotation of the body 102 through the handle 1610.Implantation tool 1600 also has an internal shaft 1612 centered aboutthe luminal axis 1604 which is both slidably translatable and slidablyrotatable within the outer cannula 1602. In the illustrated embodiment,the internal shaft 1612 is directly attached to control member 1614 suchthat rotation and translation of control member 1614 rotates andtranslates the internal shaft 1612. In this embodiment, the controlmember 1614 is wholly received within an aperture 1616 in the handle. Inother embodiments, the aperture is sized only to receive the internalshaft 1612 such that the control member 1614 remains outside of thehandle. Control member 1614 may have raised ridges, protrusions,texturing, grips, or other mechanisms to assist a user of the device torotate and translate the control member 1614.

In some embodiments, at the distal end of shaft are pins 1618 whichcorrespond to the coupling mechanism in the form of slots 1504 locatedon the distal aperture 1502 of the intervertebral cage apparatus 1500.Since shaft 1612 is slidably translatable and slidably rotatable withinthe outer cannula 1602, the shaft 1612 can be both be translated androtated to engage the “L-shaped” slot 1504 of the distal aperture 1502while a counter-force is applied to the body 102 via the outer cannula1602 due to the engagement of the mating portions 1608 with the cutouts1506.

FIG. 17 illustrates one method by which the implantation tool 1600 canbe used to convert the intervertebral cage apparatus 1500 and any othersuch apparatus described herein from an undeployed position to adeployed position. In the illustrated embodiment, a shaft 1612 with pins1618 and an intervertebral cage apparatus 1500 with a distal aperture1502 containing slots 1504 is used. During a first step, theimplantation tool 1600 is advanced towards the proximal end 110 of theintervertebral cage apparatus 1500 in the undeployed configuration suchthat the connector 1606 is placed adjacent to and in contact with theproximal end 110 of the body 102. During this advancement process,mating portions 1608 are simultaneously inserted into and engage thecutouts 1506 thereby linking the rotation of the body 102 with therotation of the outer cannula 1602.

During a second step, the shaft 1612 is then slidingly advanced distallythrough the outer cannula 1602 and into the intervertebral cageapparatus 1500. The shaft advances first through the proximal aperture124, then through the internal volume 126, and finally placed adjacentto and in contact with the trailing edge of the distal aperture 1502. Inthis embodiment, since the distal aperture 1502 has slots 1504 whichcorrespond to the pins 1618 at the distal end of the shaft 1612, theshaft 1612 can be further advanced into the distal aperture 1502 byfollowing the profile of the slot 1504. The shaft 1612 can then berotated such that the shaft 1612 is engaged with the distal aperture1502. In this engaged position, the shaft 1612 and body 102 are linkedsuch that translation of the shaft 1612 results in translation of thebody 1502. Note that the labeling of the above steps as “first” and“second” is used solely to describe one method of deploying theintervertebral cage apparatus 1500 and other cage apparatuses describedherein. In other embodiments, this sequence can be reversed such thatthe second step is completed before the first step.

In embodiments of the intervertebral cage apparatus 1500 having slots1504 which extend throughout the length of the distal aperture 1502, theshaft is advanced wholly through the distal aperture 1502. Upon the pins1618 being distal the distal face 1505 of the body 102, the shaft 1612is rotated and retracted such that the pins 1618 are abutting a distalface 1505.

Additionally, the above described steps can either be performed prior toor after insertion of the intervertebral cage apparatus 1500 into theintervertebral space. In embodiments where the above-described steps areperformed prior to insertion into the intervertebral space, theimplantation tool 1600 is used to deliver the device into the space. Inembodiments where the above-described steps are performed afterinsertion into the intervertebral space, a separate tool may be used todeliver the device into the space.

During the third step, after the shaft 1612 has been engaged with thedistal aperture 1502, a force is applied, in the distal direction, tothe proximal end 110 of the body 102 while the shaft 1612 is held inplace. The force applied to the proximal end 110 causes the body 102 toconvert from the undeployed position to the deployed position due todeformation along flexible connectors 118. In an alternative embodiment,a force is applied, in the proximal direction, to the distal end of thebody 102 at the distal aperture 1502 while the outer cannula 1602 isheld in place to convert the body 102 from an undeployed position to adeployed position.

During the final step, the shaft 1612 is rotated to disengage pins 1618from the “L-shaped” slot of the distal aperture 1502. The shaft 1612 isthen slidingly retracted from the intervertebral cage apparatus 1500such that the shaft 1612 is removed from the body 102. The connector1606 may then be retracted such that the mating portions 1608 areremoved from cutouts 1506. The tool may then be removed from theintervertebral space and the body of the patient.

Various modifications to the implementations described in thisdisclosure may be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the principles and features disclosed herein.

What is claimed is:
 1. An intervertebral cage apparatus comprising: anintervertebral cage configured to be moved from a first undeployedposition to a second deployed position, wherein the intervertebral cagecomprises: a body having a plurality of segments connected to each otherby flexible connectors, wherein the flexible connectors comprise livinghinges; and wherein the movement of the cage from the first position tothe second position decreases the distance between a proximal end and adistal end of the cage and increases a width of the body; a deploymenttool comprising: a deployment cable having a first end and a second end;and a controller, wherein the first end of the cable is connectable to aportion of the intervertebral cage and wherein the second end isconnected to the controller, and wherein manipulation of the controllertransmits force to the cable to move the intervertebral cage from thefirst position to the second position, wherein the deployment cableincludes regularly spaced features configured to allow determination ofwhether and/or to what extent the intervertebral cage is deployed byallowing the determination of a length of the deployment cable withinthe intervertebral cage.
 2. The intervertebral cage apparatus of claim1, wherein the intervertebral cage is configured to change its dimensionalong each of a longitudinal axis, a lateral axis, and a vertical axiswhen the intervertebral cage is moved from a first undeployed positionto a second deployed position.
 3. The intervertebral cage apparatus ofclaim 1, wherein the intervertebral cage comprises: a first opening at aproximal end of the cage configured to attach to the first end of thedeployment cable; one or more openings at a distal end of the cage; andand a second opening at a proximal end of the cage; wherein the cable isconfigured to extend from the first opening to an opening at the distalend of the cage, and to extend from an opening at the distal end of thecage through the second opening and to the controller.
 4. Theintervertebral cage apparatus of claim 1, wherein the intervertebralcage comprises a circuitous body partially defining an internal volume.5. The intervertebral cage apparatus of claim 1, further comprising avariable volume pouch comprising a first end comprising an opening and asealed end located opposite the first end, wherein the variable volumepouch is positionable in an internal volume of the intervertebral cagesuch that the first end is proximate to a proximal aperture of theintervertebral cage.
 6. The intervertebral cage apparatus of claim 5,wherein the variable volume pouch is affixed to the intervertebral cage.7. The intervertebral cage apparatus of claim 6, wherein the variablevolume pouch is affixed to the intervertebral cage using the deploymentcable.
 8. The intervertebral cage apparatus of claim 1, wherein theintervertebral cage comprises a memory material.
 9. The intervertebralcage apparatus of claim 1, wherein the intervertebral cage comprises aPEEK material.
 10. The intervertebral cage apparatus of claim 1, whereinthe deployment tool is further configured to facilitate in the insertionof the intervertebral cage apparatus.
 11. The intervertebral cageapparatus of claim 1, further comprising an insertion tool configured tofacilitate in the insertion of the intervertebral cage apparatus. 12.The intervertebral cage apparatus of claim 1, wherein the deploymentcable is configured for use as a marker.
 13. The intervertebral cageapparatus of claim 1, wherein the marker may be used to indicate theposition of the intervertebral cage and/or the extent the intervertebralcage has been deployed.
 14. The intervertebral cage apparatus of claim1, wherein the deployment cable further includes a locking featureconfigured to lock the intervertebral cage in the second deployedconfiguration.
 15. The intervertebral cage apparatus of claim 1, furthercomprising a plurality of deployment cables.
 16. An intervertebral cageapparatus comprising: an intervertebral cage configured to be moved froma first undeployed position to a second deployed position, wherein theintervertebral cage comprises: a body having a plurality of segmentsconnected to each other by flexible living hinge connectors; and adeployment cable coupled to the cage body between a proximal end and adistal end; wherein apply a force to the deployment cable deploys theintervertebral cage from the first undeployed position to the seconddeployed position, wherein the movement of the cage from the firstposition to the second position decreases the distance between theproximal end and the distal end of the cage and increases a width of thebody, wherein the deployment cable includes regularly spaced featuresconfigured to allow determination of whether and/or to what extent theintervertebral cage is deployed by allowing the determination of alength of the deployment cable within the intervertebral cage.
 17. Theintervertebral cage apparatus of claim 16, further comprising adeployment tool configured to engage with the intervertebral cage anddeployment cable, wherein the deployment cable is configured to transfera force from the deployment tool to the intervertebral cage to controlthe deployment of the intervertebral cage.
 18. The intervertebral cageapparatus of claim 17, wherein the deployment tool is further configuredto facilitate in the insertion of the intervertebral cage apparatus. 19.The intervertebral cage apparatus of claim 16, further comprising aninsertion tool configured to facilitate in the insertion of theintervertebral cage apparatus.
 20. The intervertebral cage apparatus ofclaim 16, wherein apply a force to the deployment cable includes thedeployment cable transferring a force from a deployment tool.
 21. Theintervertebral cage apparatus of claim 16, wherein the intervertebralcage further includes at least one distal opening and the at least oneproximal opening, the deployment cable end coupling with the at leastone distal opening and the at least one proximal opening and extendingfrom the proximal to distal end.
 22. The intervertebral cage apparatusof claim 21, wherein the at least one distal opening and the at leastone proximal opening are connected to one or more channels that passthrough all or portions of the intervertebral cage.
 23. Theintervertebral cage apparatus of claim 16, wherein the deployment cableis configured for use as a marker.
 24. The intervertebral cage apparatusof claim 16, wherein the marker may be used to indicate the position ofthe intervertebral cage and/or the extent the intervertebral cage hasbeen deployed.
 25. The intervertebral cage apparatus of claim 16,wherein the deployment cable further includes a locking featureconfigured to lock the intervertebral cage in the second deployedconfiguration.
 26. The intervertebral cage apparatus of claim 16,wherein intervertebral cage comprises a circuitous body partiallydefining an internal volume.
 27. The intervertebral cage apparatus ofclaim 16, wherein the intervertebral cage is configured to change itsdimension along at least one of a longitudinal axis, a lateral axis, anda vertical axis when the intervertebral cage is moved from theundeployed position to the deployed position.
 28. The intervertebralcage apparatus of claim 16, wherein the intervertebral cage isconfigured to change its dimension along each of a longitudinal axis, alateral axis, and a vertical axis when the intervertebral cage is movedfrom the undeployed position to the deployed position.
 29. Theintervertebral cage apparatus of claim 16, wherein the intervertebralcage comprises a lateral split dividing the body at least partially intoa top portion and a bottom portion.
 30. The intervertebral cageapparatus of claim 16, further comprising a plurality of deploymentcables.